There are many circumstances, e.g., after pelvic reconstructive surgery and/or anti-incontinence surgery, abdominal trauma or hernia, urinary infection, or the like, which can result in unpredictable delays in urination and may require that a female patient be provided with a catheter to enable her efficiently to void urine from her bladder either as her needs dictate or continuously.
Initially, generally during a time when the patient is recuperating in a hospital and under medical observation, it may be desirable to provide for constant drainage of urine from her bladder. Sometimes such a need continues even after recuperation, and the healed patient may for a long time have to wear a catheter that provides continuous drainage of urine into a receptacle like a small bag that is worn on the body and has to be periodically replaced. There are certain problems and discomforts associated with this. For example, ambulatory patients typically have their urine-collection bag strapped to a leg so that it is lower than the pelvis, and urine flow is gravity-driven down into the bag. This can be physically awkward, can be unsightly, and may adversely affect the user's psychological sense of well-being.
A commonly used catheter for continuous drainage of urine is some form of the indwelling Foley catheter, a distal end of which is inserted into the user's bladder through her urethra and is thereafter retained in place by inflation of a balloon-like element. This type of catheter is known to cause discomfort and irritation of the trigone, often causing bladder spasm. Often the catheter must be replaced by a doctor after removal due to continued bladder dysfunction. Various improvements have been suggested to alleviate the problems of tissue compression, irritation, infection and the like that are sometimes encountered in use of the Foley catheter, for example, as disclosed in U.S. Pat. No. 5,562,622, to Tihon, titled "Self-cleansing Bladder Drainage Device". U.S. Pat. No. 4,738,667, to Galloway, titled "Preformed Catheter Assembly" offers an alternative structure, in which the continuously draining catheter has a pre-curved distal end shape which, after its placement in functional position, tends to retain it in the bladder without a balloon or the like. A somewhat similar solution is taught in U.S. Pat. No. 3,490,456, to Kortum, titled "Intrauterine Catheter Anchor". Among the complications that, while rare, can occur in the placement and use of a suprapubic catheter are hematuria, cellulitis, bowel injury, urine extravasation, and catheter fracture.
Another alternative for continuous drainage is the use of a suprapubic catheter, but this too has its own problems and is not particularly favored by patients.
Intermittent self-catheterization, a third alternative, is often difficult for many patients to perform, as they may not readily be able to locate the urethra.
It is considered that the ideal mechanism would be one which will enable the patient to void spontaneously and conveniently, to check the efficiency of her voiding, and to be so comfortable and manageable that she can do all this entirely on her own and free of the need to repeatedly call or visit her doctor. The mechanism and the method of using it should be safe, and should not lead to any infection rates higher than those encountered with conventional catheter systems.
The present invention is intended to fulfill this long felt but hitherto unmet need.